Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain

NCT03155945 | Completed Phase 2 Results FDA Drug

• 1 other identifier: APD371-004
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this randomized, open-label, parallel, phase 2a study is to determine the tolerability, pharmacokinetics, and efficacy of olorinab in participants with Crohn's disease experiencing abdominal pain.

Conditions

Crohn's Disease; Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  TEAE was defined as an adverse event (AE) that occurred after first dose of olorinab. A SAE was any untoward medical occurrence that at any dose resulted in the following outcomes: death, was life-threatening, required/prolonged hospitalization, disability/incapacity, congenital anomaly/birth defect, and important medical events. Safety was assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

  Up to approximately 12 weeks

Other Outcomes (11)

• Exploratory - Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Olorinab and Its Metabolites at Week 8

  Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose

• Exploratory - Median Time for Cmax (Tmax) of Olorinab and Its Metabolites at Week 8

  Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose

• Exploratory - Mean Area Under the Concentration Time Curve From Time of Dosing to 8 Hours Post-dose (AUC0-8) of Olorinab and Its Metabolites at Week 8

  Week 0 (Day 1, Day 2), Week 8 (Day -1), Week 8: Pre-dose, 0.5, 1, 2, 4, 6 and 8 hours post-dose

Study Arms (2)

Olorinab 25 mg TID

EXPERIMENTAL

Participants received olorinab 25 milligrams (mg) tablet by mouth, three times daily (TID) for 8 weeks

Drug: Olorinab

Olorinab 100 mg TID

EXPERIMENTAL

Participants received olorinab 100 mg oral tablets TID for 8 weeks

Drug: Olorinab

Interventions

Olorinab DRUG

Olorinab active treatment for 8 weeks.

Also known as: APD371

Olorinab 100 mg TID; Olorinab 25 mg TID

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of Crohn's disease for at least 3 months prior to screening corroborated by prior endoscopic and histopathologic documentation consistent with Crohn's disease.
• Quiescent to mildly active inflammatory Crohn's disease defined with a total of simple endoscopy score for Crohn's disease (SES-CD) score of \< 10 or fecal calprotectin \< 500 mcg/g within 4 weeks before Screening.
• Moderate to severe abdominal pain as defined by average abdominal pain score (AAPS) of \>/= 4points on 7 consecutive days of the screening period up to Day -2. AAPS will be based on the 11-point numeric rating scale where 0 (no abdominal pain) to 10 (worst possible abdominal pain).

You may not qualify if:

• Female participants who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 prior to study drug administration.
• Recent history (within 6 months of screening visit) of cerebrovascular disease, Acute Coronary Syndrome, Cerebrovascular accident, Transient ischemic attack, Myocardial infarction, unstable angina.
• Other significant chronic pain conditions that in the opinion of the Investigator may influence the abdominal pain score.
• History of extensive colonic resection, subtotal or total colectomy.
• History of \>3 small bowel resections or diagnosis of short bowel syndrome or who have undergone bowel resection within 6 months prior to randomization.
• Chronic active hepatitis B within the last year (unless shown at the time of study entry to be hepatitis B antigen negative) or any history of hepatitis C.
• Evidence of current gastro-intestinal infection (bacterial or parasitic) or significant infection within 45 days of screening.

Sponsors & Collaborators

• Arena Pharmaceuticals: lead

Study Sites (7)

Clinical Research of Brandon

Brandon, Florida, 33511, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

MultiCare Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• Castro J, Garcia-Caraballo S, Maddern J, Schober G, Lumsden A, Harrington A, Schmiel S, Lindstrom B, Adams J, Brierley SM. Olorinab (APD371), a peripherally acting, highly selective, full agonist of the cannabinoid receptor 2, reduces colitis-induced acute and chronic visceral hypersensitivity in rodents. Pain. 2022 Jan 1;163(1):e72-e86. doi: 10.1097/j.pain.0000000000002314.

  PMID: 33863856 DERIVED

MeSH Terms

Conditions

Crohn Disease; Abdominal Pain

Interventions

olorinab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Results Point of Contact

• Title: Arena CT.gov Administrator
• Organization: Arena Pharmaceuticals, Inc.

ct.gov@arenapharm.com

+1 855-218-9153

Study Officials

• Arena CT.gov Administrator

  Arena Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 16, 2017
• Study Start: July 19, 2017
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Locations

US (7)